FDA UDI
In Commercial Distribution
🇺🇸 United States
Optilume BPH Drug Coated Balloon Catheter
DI: 00853095008532
·
Model: 1113
·
Urotronic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optilume BPH Drug Coated Balloon Catheter
- Primary DI
- 00853095008532
- Version / Model
- 1113
- Catalog Number
- 1113-30045
- Company Name
- Urotronic, Inc.
- Labeler DUNS
- 080558603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-05
- Public Version
- 1
- Public Version Date
- 2023-08-14
- Public Version Status
- New
- Public Device Record Key
- dbf73d29-502b-414e-a306-31ec7d79850e
Device Description
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QXB | Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63213 | Urethral dilatation catheter, drug-eluting | A sterile, flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage; it includes a drug (e.g., chemotherapy drug) intended to be eluted in situ. The device is typically designed with an inflatable dilation balloon. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853095008532 | GS1 |
Customer Contacts
- Phone
- 763.285.7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220029 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 30 | Millimeter | |
| Balloon Length | 45 | Millimeter | |
| Balloon Rated Burst Pressure | 4 | Atmosphere |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius